European Commission Approves Merck’s KEYTRUDA (pembrolizumab) Plus Chemotherapy as Treatment for Certain Patients With Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)

Merck, known as MSD outside the United States and Canada, announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease. Triple-negative breast cancer is an aggressive type of breast cancer. This represents KEYTRUDA’s first approval in Europe in a breast cancer setting.

The approval is based on final analysis from the Phase 3 KEYNOTE-355 trial, in which KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) significantly improved overall survival (OS), reducing the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093), and progression-free survival (PFS), reducing the risk of disease progression or death by 34% (HR=0.66 [95% CI, 0.50-0.88]; p=0.0018) compared to chemotherapy alone in these patients. In this trial, 38% of enrolled patients had tumors expressing PD-L1 with CPS ≥10.

“This approval is an important milestone for appropriate patients with metastatic TNBC who are in need of new treatment options,” said Dr. Javier Cortés, head of the International Breast Cancer Center (IBCC), Quironsalud Group. “With this approval, patients in Europe with metastatic TNBC whose tumors express PD-L1 (CPS ≥10) have a new immunotherapy treatment option that can be used in combination with different chemotherapy agents.”

“At Merck, we are committed to improving outcomes for people with difficult-to-treat cancers, such as TNBC, around the world and are proud of this first European approval for KEYTRUDA in a breast cancer setting,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “Now patients with metastatic TNBC who have tumors that express PD-L1 (CPS ≥10) in Europe have the new option of KEYTRUDA in combination with chemotherapy, a regimen that has shown significant improvement in overall survival. Today marks an important step forward in the treatment of this aggressive disease.”

This approval allows marketing of the combination with KEYTRUDA in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

Merck is committed to delivering meaningful advances in breast cancer and women’s cancers. The company is rapidly advancing a broad portfolio in gynecologic and breast cancers through an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across these areas.